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Infliximab Effective for Ulcerative Colitis for Up to 2 Years: Presented at DDW
By Bruce Sylvester
WASHINGTON, DC -- May 24, 2007 -- Extensions trials of infliximab therapy for ulcerative colitis show that infliximab responders with initial moderate to severe disease maintain a treatment response for up to 2 years, researchers reported here at Digestive Diseases Week (DDW).
"Infliximab is effective for long-term therapy," said presenter and investigator Walter Reinisch, MD, professor and medical specialist in internal medicine at the University Hospital of the University of Vienna in Vienna, Austria. "And not only did patients with moderate to severe disease maintain a therapeutic benefit for 2 years, almost all of them were off corticosteroids after 2 years."
The investigators gathered and analysed data from long-term extensions of the ACT trials (Active Ulcerative Colitis 1&2) conducted in the US and Europe.
At the start of the extensions, 76% of 229 responders to active treatment in ACT 1&2 had achieved mild or no disease activity (PGA -- Physician's Global Assessment of 0 or 1), 41% of whom showed no disease.
At week 56 of the extension trials, 92% of remaining subjects had mild or no disease, 61% of whom had no disease. At week 104, 97% of the 97 remaining subjects in the extensions had mild or no disease, 75% of whom had no disease.
"These findings are particularly important for ulcerative colitis patients since it is a chronic condition with flares," Dr. Reinisch said at oral session on May 23rd. "To have a treatment that quickly reduces symptoms and that can maintain response and remission in the long term is crucial."
Corticosteroids were used less throughout the extensions, with 80%, 88%, and 98% of subjects becoming corticosteroid-free at weeks 8, 56, and 104, respectively.
Infliximab therapy was generally well tolerated, with less than 5% of subjects in the extension trials discontinuing therapy due to an adverse event.
Infliximab is currently the only antitumour necrosis factor therapy approved by the FDA for the treatment of ulcerative colitis.
The study was supported by Centocor, Inc.
[Presentation title: Infliximab is Effective as a Long-Term Treatment for Ulcerative Colitis: Results of the ACT Long Term Extension. Abstract 984]
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